10 mg / ml solution for injection / infusion
rocuronium bromide
What Rocuronium B. Braun is and what it is used for
Rocuronium B. Braun belongs to a group of medicines called muscle relaxants. In normal cases, the nerves send messages to the muscles in the form of impulses. Rocuronium B. Braun works by blocking these impulses so that the muscles become relaxed.
When you have surgery, your muscles must be completely relaxed. This makes it easier for the surgeon to operate.
In general anesthesia in adults and children, Rocuronium B. Braun can be used to facilitate the insertion of a tube into your trachea to facilitate breathing (mechanically assisted breathing) and to ensure that your muscles are relaxed during surgery.
In adults, the doctor may also use this medicine as a short-term adjunctive medication in the intensive care unit (eg to make it easier to insert a tube into the trachea). In addition, you can get this medicine in emergencies if a tube needs to be quickly inserted into the trachea before surgery.
What you need to know before you use Rocuronium B. Braun
Do not use Rocuronium B. Braun
- if you are allergic to rocuronium bromide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Rocuronium B. Braun
- if you are allergic to any muscle relaxant
- if you have any kidney, liver, or biliary tract disease
- if you have any heart disease or disease that affects your blood circulation
- if you have swelling due to fluid accumulation in the body ( edema ) (eg in the area around the ankles)
- if you have a disease that affects nerves and muscles (neuromuscular diseases, eg polio (poliomyelitis), myasthenia gravis, Eaton-Lambert syndrome)
- if you have ever had too low a body temperature under anesthesia ( hypothermia )
- if you have low calcium in your blood (hypocalcemia, caused eg by large blood transfusions )
- if you have low potassium in your blood ( hypokalaemia, caused eg by severe vomiting, diarrhea, or treatment with diuretics)
- if you have high levels of magnesium in your blood (hypermagnesemia)
- if you have low protein levels in the blood (hypoproteinemia)
- if you suffer from fluid loss
- if you have an increased amount of acids in your blood ( acidosis )
- if you have increased levels of carbon dioxide in your blood ( hypercapnia )
- if you suffer from excessive weight loss ( cachexia )
- if you are overweight or elderly
- if you have burned.
Other drugs and Rocuronium B. Braun
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines such as:
- antibiotics
- antidepressants containing lithium
- medicines to treat heart disease or high blood pressure (eg quinidine, calcium channel blockers, adrenergic blockers, eg beta-blockers , alpha-blockers )
- diuretics or diuretics (medicines that increase the amount of urine)
- certain laxatives such as magnesium salts
- quinine (used to treat pain and infection )
- drugs for the treatment of epilepsy (eg phenytoin, carbamazepine)
- long-term use of corticosteroids in the intensive care unit
- drugs for the treatment of myasthenia gravis (neostigmine, pyridostigmine, edrophonium, aminopyridine)
- theophylline (used to treat asthma )
- medicines for the treatment or prevention of viral infections ( protease inhibitors ).
Note:
You may be given other medicines during the procedure that may affect the effect of rocuronium. These include certain anesthetics (eg local anesthetics and inhaled anesthetics ), other muscle relaxants, and protamine which counteracts the anticoagulant effect (prevention of blood clots) in heparin. Your doctor will take this into account when deciding which dose is right for you.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are very limited data on the use of Rocuronium B. Braun in pregnant women and no data are available for use in breastfeeding women. Rocuronium B. Braun should only be given to pregnant and lactating women as the doctor considers that the benefits outweigh the risks. Rocuronium B. Braun can be given by cesarean section.
No data are available on the effect of this drug on fertility.
Driving and using machines
Rocuronium B. Braun has a significant effect on the ability to drive and use machines. Therefore, it is recommended not to drive or use potentially hazardous machinery for the first 24 hours after complete recovery from the effect of the drug.
Your doctor should tell you when you can start driving and using machines again. Anyone treated with Rocuronium B. Braun should always be followed home by an adult.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rocuronium B. Braun contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How to use Rocuronium B. Braun
Rocuronium B. Braun is given to you by your anesthetist. It is given intravenously either as a single injection or as a continuous infusion (over a long period) into a vein.
Adults
The usual dose is 0.6 mg per kg body weight and the effect lasts 30 – 40 minutes. During the operation, the effect of Rocuronium B. Braun is monitored continuously. Your doctor may therefore give you additional doses of the medicine depending on your situation.
If necessary, you can get extra doses. Dose one is adjusted by the anesthesiologist according to your needs. Dose one depends on many factors, such as concomitant use of other drugs (their interaction), taking into account the estimated duration of surgery as well as your age and your clinical condition.
This medicine is for single use only.
Use in children and adolescents
This medicine can be given to newborns (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years), and adolescents (12 to 17 years). The anesthetist adjusts the dose according to your child’s needs. The doctor takes into account that higher infusion rates may be necessary for children.
Experience with rocuronium bromide in a specific type of anesthesia, so-called rapid induction, is limited in children and adolescents. Rocuronium bromide is therefore not recommended for this purpose in children and adolescents.
Elderly patients, obese patients, and patients with liver and/or biliary tract disease and/or renal failure:
The doctor can, if necessary, adjust the dose depending on your situation.
If you take more Rocuronium B. Braun than you should
Your anesthetist will monitor you closely while you are being treated with Rocuronium B. Braun, so it is unlikely that you will be given too much Rocuronium B. Braun. If this happens, muscle relaxation may increase. In such cases, your anesthetist may give you medicines to relieve this effect and ensure that the anesthesia and mechanically assisted breathing continue until you breathe again by yourself.
Additional questions
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
For information intended for healthcare professionals, see the section below.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. Tell a doctor or nurse immediately if any of the following side effects occur:
Very rare (may affect up to 1 in 10,000 people):
Hypersensitivity reactions (allergic reactions) and associated symptoms. A hypersensitivity reaction may include rash, itching, difficulty breathing, low blood pressure, rapid heart rate, circulatory collapse, shock or swelling of the face, lips, throat, or tongue, hives, swelling of the skin, and mucous membranes, reddening of the skin. In addition, other side effects associated with the airways may also occur during anesthesia (complications of the airways caused by anesthesia).
Has been reported (occurs in an unknown number of users)
- respiratory arrest
- respiratory failure
- severe allergic reaction with convulsions in the coronary arteries of the heart (Kounis syndrome) leading to chest pain (angina) or heart attack
Other possible side effects:
Uncommon / rare (may affect 1-10 out of 1000 people):
- increased heart rate ( tachycardia ) *
- slow recovery from anesthesia
- low blood pressure ( hypotension )
- lack of effect
- increased or decreased effect of the drug
- the body’s response to the drug may increase or decrease
- injection site pain
- prolonged duration of muscle relaxation (prolonged neuromuscular blockade)
Very rare (may affect up to 1 in 10,000 people):
- increased histamine levels in the blood
- wheezing ( bronchospasm )
- inability to move (paralysis)
- muscle weakness (after long-term use in the intensive care unit, especially in combination with cortisone ).
* Clinical studies suggest that an increased heart rate is common in pediatric patients and may occur in up to 1 in 10 people.
How to store Rocuronium B. Braun
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
After first opening: The product should be used immediately after opening the ampoule.
After dilution : Chemical and physical in-use stability using 5.0 mg / ml and 0.1 mg / ml solution (diluted with sodium chloride 9 mg / ml (0.9%) and glucose 50 mg / ml (5%) solution for infusion , solution) has been shown for 24 hours at room temperature and when exposed to daylight in glass and place packs.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before administration are the responsibility of the user and would normally not be longer than 24 hours at 2-8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear or free of particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is rocuronium bromide.
1 ml contains 10 mg of rocuronium bromide.
Each 5 ml ampoule contains a total of 50 mg of rocuronium bromide.
The other ingredients are gluconolactone, sodium acetate trihydrate, sodium citrate dihydrate, and water for injections.
What the medicine looks like and the contents of the pack
Rocuronium B. Braun is a clear, colorless to light brownish-yellow solution for injection or infusion.
Pack sizes:
Rocuronium B. Braun is available in packs of 20 plastic ampoules containing 5 ml of solution.
Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Information is provided by
B. Braun Medical AB
Box 110
18212 Danderyd
This medicinal product is authorized under the European Economic Area under the names:
| Belgium | Rocuronium B. Braun 10 mg / ml solution for injection / infusion |
| Finland | Rocuronium B. Braun 10 mg / ml |
| Greece | Rocuronium B. Braun 10 mg / ml |
| Ireland | Rocuronium 10 mg / ml |
| Italy | Rocuronio B. Braun 10 mg / ml |
| Luxembourg | Rocuronium bromide B. Brown 10 mg / ml |
| Netherlands | Rocuronium bromide B. Brown 10 mg / ml |
| Poland | Rocuronium B. Braun |
| Portugal | Brometo de Rocurónio B. Braun |
| Slovakia | Rocuronium B. Braun 10 mg / ml |
| Spain | Rocuronio B. Braun 10 mg / ml |
| UK | Rocuronium 10 mg / ml |
| Sweden | Rocuronium B. Braun 10 mg / ml |
| Czech Republic | Rocuronium B. Braun 10 mg / ml |
| Germany | Rocuronium bromide B. Brown 10 mg / ml |
| Austria | Rocuronium bromide B. Brown 10 mg / ml |